Final Patient Dosed in Mesoblast Phase 3 Trial of Revascor Cell Therapy for Advanced Heart Failure
February 19 2019 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a world leader in
development and commercialization of cellular medicines, announced
today that the last patient has now been dosed in the Phase 3
events-driven trial of its allogeneic cell therapy product
candidate Revascor for advanced chronic heart failure. The
566-patient trial will complete when sufficient primary
endpoint events have accrued, which is likely to be within 12
months.
Results from a prior Phase 2 trial identified the patients most
likely to benefit from Revascor as being those at high risk of
recurrent hospitalization events and death. These results guided
the trial design and selection criteria for enrollment of high-risk
patients in the current Phase 3 trial in order to maximize the
probability that the Phase 3 results would confirm the Phase 2
results.Consequently, the Company is confident that the total
number of randomized patients enrolled in the Phase 3 trial is
sufficient to show whether Revascor is superior to placebo in the
trial’s primary endpoint of reduction in heart failure-related
hospital admissions, and in the key secondary endpoint of reduction
in cardiac deaths. In April 2017, the Phase 3 trial was successful
in a pre-specified futility analysis of the primary efficacy
endpoint in the first 270 patients.Mesoblast’s cardiovascular
partner in China, Tasly Pharmaceutical Group, is planning to meet
with the National Medical Products Administration (NMPA) of China,
formerly known as the China Food and Drug Administration, in the
first quarter 2019 to discuss the regulatory approval pathway for
Revascor in China. The objective is to initiate a Phase 3
trial of Revascor in China using similar clinical endpoints and
targeting a similar patient population of advanced heart failure
patients at high risk of recurrent heart failure-related
hospitalization and death. Tasly and Mesoblast will leverage
each other’s clinical trial results in China, the United States and
other territories to support their respective regulatory
submissions.About Heart Failure There are
over 8 million patients with heart failure in the United States
alone. Up to 20 percent progress to advanced heart
failure refractory to all existing medicines, categorized as
New York Heart Association Class III or IV disease. These
patients represent a major unmet medical need due to their high
rates of recurrent hospitalization, progression to end-stage
disease, and high mortality1.
About Mesoblast Mesoblast Limited (Nasdaq:MESO;
ASX:MSB) has leveraged its proprietary technology platform to
establish a broad portfolio of late-stage allogeneic
(off-the-shelf) product candidates with three product candidates in
Phase 3 trials – acute graft versus host disease, chronic heart
failure and chronic low back pain due to degenerative disc disease.
Through a proprietary process, Mesoblast selects rare mesenchymal
lineage precursor and stem cells from the bone marrow of healthy
adults and creates master cell banks, which can be industrially
expanded to produce thousands of doses from each donor that meet
stringent release criteria, have lot to lot consistency, and can be
used off-the-shelf without the need for tissue matching. Mesoblast
has facilities in Melbourne, New York, Singapore and Texas and is
listed on the Australian Securities Exchange (MSB) and on the
Nasdaq (MESO). www.mesoblast.com
1.AHA’s 2017 Heart Disease and Stroke Statistics
UpdateForward-Looking Statements This announcement
includes forward-looking statements that relate to future events or
our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make such forward-looking statements pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Forward-looking
statements should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. Forward-looking statements
include, but are not limited to, statements about the timing,
progress and results of Mesoblast’s preclinical and clinical
studies; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies; the timing or
likelihood of regulatory filings and approvals; and the pricing and
reimbursement of Mesoblast’s product candidates, if approved. You
should read this press release together with our risk factors, in
our most recently filed reports with the SEC or on our website.
Uncertainties and risks that may cause Mesoblast’s actual results,
performance or achievements to be materially different from those
which may be expressed or implied by such statements, and
accordingly, you should not place undue reliance on these
forward-looking statements. We do not undertake any obligations to
publicly update or revise any forward-looking statements, whether
as a result of new information, future developments or
otherwise.
For further information, please
contact: |
Julie Meldrum |
Schond Greenway |
Corporate Communications |
Investor Relations |
T: +61 3 9639 6036 |
T: +1 212 880 2060 |
E: julie.meldrum@mesoblast.com |
E: schond.greenway@mesoblast.com |
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